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Regulatory Focus™ > News Articles > 2021 > 2 > House committee proposes $500M in COVID funding for FDA

House committee proposes $500M in COVID funding for FDA

Posted 10 February 2021 | By Michael Mezher 

House committee proposes $500M in COVID funding for FDA

The House Energy and Commerce Committee will convene Thursday to markup its portions of the budget reconciliation bill that will contain President Joe Biden’s proposed $1.9 trillion COVID-19 relief package.
The budget reconciliation process was created under the Congressional Budget Act of 1974 and enables Congress to fast-track legislation related to taxes, spending and debt limits. Democrats have opted to use the process to allow them to pass the stimulus package without Republican support in the 50-50 split Senate.
Nestled within the more than $100 billion in funding the committee is proposing is a $500 million boost to FDA “to support the review, facilitate the development and post-market surveillance of COVID-19 vaccines and therapeutics, and address drug shortages, among other activities.”
Those other activities include facilitating the use of continuous manufacturing for vaccines and related materials and carrying out inspections for vaccines, therapeutics and medical devices that were delayed or canceled during the pandemic.
The “no-year” funds are a welcome boost for the agency, the Alliance for a Stronger FDA said in a statement.
“The FDA stakeholder community appreciates and supports the House Energy and Commerce Committee’s decision to include $500 million in no-year money to support COVID-19 activities at FDA. This assures that FDA has the funds it needs as its workload grows and shifts in response to the pandemic. Neither the pandemic nor FDA responsibilities in this area can be neatly segmented by fiscal year, so the flexibility provided by these funds is enormously valuable,” the group said.
While FDA was able to meet most of its user fee goals for FY2020, the agency was unable to conduct some preapproval inspections and postponed nearly all surveillance inspections due to the pandemic.
FDA has also been inundated with its pandemic-related workload. The agency has seen an influx of investigational new drug applications and emergency use authorization requests for COVID-19 products and has issued more than 70 guidances as part of its response to the pandemic, on top of its existing workload.
House Committee on Energy and Commerce


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